Meet CrowdCovid (Example Medical Device Software For IEC 62304 Compliance)
Dr. Oliver Eidel
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Clinical Evaluation
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Updated August 11, 2026
When you develop software as a medical device (SaMD), your software needs to be developed and documented in an IEC 62304 - compliant way.
So - what do you need to be IEC 62304 compliant? Well, I could give you an abstract talk about what's written in the regulation, or I could just show you an example software and we could see how we'd document it in a IEC 62304 - compliant way.
So let's get started and look at CrowdCovid, the example application for your IEC 62304 documentation project.
This video is part of our free medical device compliance library. Browse all videos on our website, watch them on the OpenRegulatory YouTube channel, or follow the courses inside Formwork.
So - what do you need to be IEC 62304 compliant? Well, I could give you an abstract talk about what's written in the regulation, or I could just show you an example software and we could see how we'd document it in a IEC 62304 - compliant way.
So let's get started and look at CrowdCovid, the example application for your IEC 62304 documentation project.
This video is part of our free medical device compliance library. Browse all videos on our website, watch them on the OpenRegulatory YouTube channel, or follow the courses inside Formwork.
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I’m a medical doctor, software engineer and regulatory dude. I’m also the founder of OpenRegulatory.
Through OpenRegulatory, I’ve helped 100+ companies with their medical device compliance. While it’s also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)
If you’re still lost and have further questions, reach out any time!
Through OpenRegulatory, I’ve helped 100+ companies with their medical device compliance. While it’s also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)
If you’re still lost and have further questions, reach out any time!
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